Material, Tooth Shade, Resin
Dental · 21 CFR 872.3690
Recent MDR events
961 adverse event reports on file
- CAMOUFLAGE NOW MILLING BLOCKS; GD-MANDREL; A2 LT; 14 (5 UNITS)Aug 7, 2025InjuryPrismatik Dentalcraft, Inc.3011649314-2025-00879
- VENUS BULK FLOW SYR 1 X 2G ONEOct 10, 2024InjuryKulzer Gmbh - Hq3005665377-2024-00002
- VENUS BULF FLOW SYR 1 X 2G ONEOct 8, 2024InjuryKulzer, Gmbh-hq1821514-2024-00002
- SURFL SDR FLOW+ CMPL REF UNIVJun 11, 2024InjuryDentsply Llc2515379-2024-00027
- DENTAL COMPOSITEFeb 27, 2024InjuryUnknownMW5152185
- 3M FILTEK COMPOSITE FILLINGJan 10, 2024Injury3m Espe Dental ProductsMW5150128
- VENUS FLOW SYR 1 X 1,8G - A3Nov 21, 2023InjuryKulzer Gmbh - Hq3005665377-2023-00008
- VENUS FLOW SYR 1 X 1,8G - A3Nov 21, 2023InjuryKulzer, Gmbh-hq1821514-2023-00008
- VOCO CLIPOct 6, 2023InjuryVoco Gmbh8010908-2023-00005
- SDI SUPER ETCHJ JUMBO 37%Sep 8, 2023InjurySdi LimitedMW5145457
Event type breakdown
Recalls
69 recall events for this product code
- Ultradent Products, Inc.Open, ClassifiedSep 6, 2024
Brand Name: Vit-l-escence
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3066-2024 · View FDA record ↗ - Ultradent Products, Inc.Open, ClassifiedSep 6, 2024
Brand Name: Transcend
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3067-2024 · View FDA record ↗ - Ultradent Products, Inc.Open, ClassifiedSep 6, 2024
Brand Name: Transcend
Due to a manufacturing issue, red particulates present in the expressed composite.
Z-3068-2024 · View FDA record ↗ - Voco GmbHTerminatedOct 1, 2019
Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure s
The metal cannula are potentially too loose and may become loose when applying the filing material.
Z-0028-2020 · View FDA record ↗ - 3M Company - Health Care BusinessTerminatedJul 8, 2015
Block Versions Used by Dental Offices often referred to as chairside milling:
3M is initiating a Field Correction to remove the crown indication from all Lava Ultimate products. These products will continue to be indicated for onlays, inlays and veneers.
Z-2052-2015 · View FDA record ↗ - Kerr/Pentron, DBA Kerr Corporation and Pentron ClinicalTerminatedSep 19, 2013
NX3 Try-In Gel. The product is used as a tooth shade resin material.
Kerr Corporation is voluntarily recalling one lot of NX3 Try-In Gel, because some of the NX3 Try-In Gel syringes in the affected lot contain a different product material. The material in the affected syringe does not match the shade of the cement as it is labeled.
Z-2259-2013 · View FDA record ↗ - Kerr CorporationTerminatedFeb 28, 2012
Brand Name: Fusio Liquid Dentin, part number N21SB, N21SC.
A recall was initiated because Pentron Clinical has confirmed that the Fusio Liquid Dentin is not as flowable as ideally expected.
Z-1115-2012 · View FDA record ↗ - Sybron Dental SpecialtiesTerminatedFeb 13, 2012
Artiste Flowable Value Pack Part Number N28VA, Syringe Lot Number 165741
The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude.
Z-1000-2012 · View FDA record ↗ - Sybron Dental SpecialtiesTerminatedFeb 13, 2012
Artiste Flowable Part Number N28A, Syringe Lot Number 165741
The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude.
Z-1005-2012 · View FDA record ↗ - Sybron Dental SpecialtiesTerminatedFeb 13, 2012
Flow Tec Part Number 3784-514, Syringe Lot Number 165741
The recall was initiated because Pentron Clinical has confirmed the Flow Tec Nano Hybrid Flowable Composite material has been found to be difficult to extrude.
Z-1006-2012 · View FDA record ↗
Registered firms
1,186 firms currently registered for this product code
Solventum Us Llc
Eagan, MN, US
Oketz Logistics Llc
Coral Gables, FL, US
Kerr Corporation
ORANGE, CA, US
3d Dental Desings And Development
Shaker Heights, OH, US
Kulzer Gmbh
HANAU Hesse, DE
Zest Anchors, Llc
Carlsbad, CA, US
Titanlinks Logistics Llc
Newark, DE, US
Coltene/whaledent Ag
ALTSTAETTEN Sankt Gallen, CH
Solventum Us Llc
Irvine, CA, US
Prais Reliable Dental Supplies S.a
Victoria Grand Anse Mahe, SC
Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
SAO CARLOS Sao Paulo, BR
Worldwide Supplies Limited
Hong Kong, HK
Mainline Medical Dental Supply
North York Ontario, CA
Indigodental Gmbh
Pinneberg Schleswig-Holstein, DE
Tokuyama Dental Corporation Kashima Factory
Kamisu-shi Ibaraki, JP
Sdi Ltd.
BAYSWATER Victoria, AU
Bisco, Inc.
Schaumburg, IL, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
510(k) clearances
934 clearances for this product code
- Ivoclar Vivadent, Inc.Jul 1, 2026
K261485 · Tetric plus Fill;Tetric plus Flow
- Ultradent Products, Inc.Jul 1, 2026
K262228 · Transcend Bulk Fill Flowable Composite
- GC America, Inc.Jun 18, 2026
K261246 · SRGC-06
- DiaDent Group InternationalJun 2, 2026
K261093 · DIAFIL
- DiaDent Group InternationalMay 19, 2026
K261071 · DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
- Vericom Co., Ltd.May 11, 2026
K260805 · Dual Core
- Voco GmbHApr 27, 2026
K261357 · Grandio disc multicolor
- Hangzhou SHINING3D Dental Technology Co., Ltd.Apr 27, 2026
K261356 · Dura-Crown